For Responsible Persons (RP), Qualified Persons (QP) & RA teams

Every market. Every pathway. One source of truth.

Authority-cited country profiles for 15 markets, including the only structured database of unlicensed medicine pathways. Reviewed quarterly by named regulatory contributors.

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Country regulatory profiles

Identical structure across 15 markets — authorities, MA pathways, fees, timelines, MAH/RP requirements, post-approval lifecycle. Every figure is sourced.

Unlicensed medicine pathway database

Named patient supply, compassionate use, and emergency import — with legal basis, approval authority, documentation, and timeline. The only structured database of its kind.

Side-by-side country comparison

Benchmark timelines, fees, reliance pathways, and local-presence requirements across up to three markets. Replaces the spreadsheet you've been maintaining.

See for yourself

A profile you can interrogate, not just read

Every page is structured the same way: authority, pathways, fees, timelines, MAH and RP requirements, post-approval, supply chain, pricing. Every figure is linked to its primary source. Every section carries a freshness and confidence indicator.

Linked sources at section level — never a free-floating claim.
Tracks fee revisions, pathway changes, and lifecycle reform.
Named contributor on every page — full credentials disclosed.

Open UK sample Read methodology

🇬🇧

United Kingdom

MHRA · Europe

15 markets, identical structure

From the FDA to PMDA — side-by-side comparable.

Editorial standards

Built like a regulatory publication, not a SaaS dashboard

Tier-1 source hierarchy. Quarterly full audits. Named contributors with disclosed conflicts of interest. Every claim is linked to its primary source.

Quarterly full audit

Every country profile re-verified end-to-end against primary sources at minimum every 90 days.

Tier-1 source hierarchy

Authority publications first. Consultancy and academic sources only ever as triangulation.

Named contributors

Every profile carries a contributor name and credentials. We do not anonymise authorship.

Read full methodology

Criterion	🇬🇧 UK	🇪🇺 EU	🇺🇸 US
Lead pathway	IRPIRP	Centralised	NDANDA
Approval (days)	60–110	210	180–360
English subs	Yes	Yes	Yes
Local rep	Not required	MAHMAH in EU/EEA	US agent
Reliance	8 agencies	—	—
HTAHTA	NICENICE/SMCSMC	Member-state	—

Lead pathway

🇬🇧 UKIRPIRP
🇪🇺 EUCentralised
🇺🇸 USNDANDA

Approval (days)

🇬🇧 UK60–110
🇪🇺 EU210
🇺🇸 US180–360

English subs

🇬🇧 UKYes
🇪🇺 EUYes
🇺🇸 USYes

Local rep

🇬🇧 UKNot required
🇪🇺 EUMAHMAH in EU/EEA
🇺🇸 USUS agent

Reliance

🇬🇧 UK8 agencies
🇪🇺 EU—
🇺🇸 US—

HTAHTA

🇬🇧 UKNICENICE/SMCSMC
🇪🇺 EUMember-state
🇺🇸 US—

Stop maintaining the spreadsheet

Side-by-side comparison across markets

Pick two or three countries. Get every criterion an RPRP or QPQP actually files against — timelines, fees, MAHMAH residency, local responsible person, GMPGMP inspection, accelerated pathways, post-approval framework, HTAHTA. Save the view, share it.

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Stop second-guessing the regulatory map

Country profiles you can interrogate. Pathways you can compare. An assistant grounded in the same source-cited dataset.

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